Course Description

Course title:

ISO 14155:2011 - Clinical Investigation Close Out

Course ID: 65

Course Description:

This course explores the requirements for both premature terminations and temporary suspensions of clinical investigations. It also reviews the process of resuming routine clinical investigation close outs.

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Learning Objectives:

Upon successfully completing this course, learners will be able to:

Close down or temporarily suspend a clinical investigation in a given site or throughout all sites involved

Recognize that documenting all actions is mandatory

Take into account that the essential documents referred to in Annex E of ISO 14155 must be kept in a traceable manner for a period of time determined by regulatory authorities

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